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Completed

NCT Number: NCT02935439

A Novel Fully Integrated Mobile Management Solution Using Cell Phone Technology for Heart Failure

The purpose of this research study is to learn about the use of a cell phone for monitoring patients with heart failure. Participants will be asked questions about their heart failure daily and participants will need to answer them. The investigator will try to assess if the questions are easily understood by the participants. The investigator will also assess if the phone-based system for monitoring is easy to use by the participants. The investigator will also assess if the daily questions and interactions increase the self-efficacy, knowledge, and quality of life of participants related to their heart failure.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Miami VA Healthcare System

Miami, Florida, 33125, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have a diagnosis of heart failure
  • Have an anticipated survival ≥ 6 months
  • Receive care at the University of Miami or Jackson Healthcare system
  • 18 years or older
  • Able to communicate in English and/or Spanish
  • Able to operate a cell phone, read, understand, and respond to the questions on the cell phone, and are able to use the weight scale.

Exclusion criteria

  • Previous history of unstable coronary syndromes
  • History of end-stage heart failure or heart transplantation

Treatment and study plan

Cell Phone

Other

Participants responded to questions about their heart failure symptoms using a cell phone.

Primary outcomes

  1. Self-Efficacy for Managing Chronic Disease

    Time frame: 90 days

    This was used from the Chronic disease self-management program scales. (http://patienteducation.stanford.edu/research). Well-validated scale rating patient's confidence in managing chronic illness. It covers several areas of chronic diseases including symptom control, role functions, emotional functioning, and communicating with physicians. The English version has 6-items, while the Spanish version has 4-items.16 Using a Likert scale with item scores ranging from 1 to 10; scale score is the mean of the items.

Secondary outcomes

  1. Health Distress Scale

    Time frame: 90 days

    This was used from the Chronic disease self-management program scales. (http://patienteducation.stanford.edu/research). Measures the distress associated with health problems over the last month. Using a Likert scale with item scores ranging from 0 to 5, scale score is the mean of the four items.

  2. Communication with Physicians

    Time frame: 90 days

    This was used from the Chronic disease self-management program scales. (http://patienteducation.stanford.edu/research). Measures key behaviors to assess how well patients communicate with their healthcare providers. Using a Likert scale with item scores ranging from 0 to 5, scale score is the mean of the three items.

  3. Fatigue Visual Numeric

    Time frame: 90 days

    This was used from the Chronic disease self-management program scales. (http://patienteducation.stanford.edu/research). Assesses self-reported fatigue in the past 2 weeks. This visual numeric scale is a modified version of the visual analog scale. It uses 10 bars of different heights and shading intensity.

  4. Shortness of Breath Visual Numeric

    Time frame: 90 days

    This was used from the Chronic disease self-management program scales. (http://patienteducation.stanford.edu/research). Assesses self-reported shortness of breath in the past 2 weeks.

  5. Heart Failure Self-Efficacy Scale-30

    Time frame: 90 days

    30-item scale developed for self-efficacy with heart failure overall and with medications, diet, symptoms, activity, and heart failure readmission. Using a Likert scale with item scores ranging from 0 to 10, scale score is the mean of the items.

  6. European Heart Failure Self-Care Behavior Scale

    Time frame: 90 days

    12-item questionnaire assesses self-care behavior of patients with heart failure. Using a Likert scale with item scores ranging from 1 to 5, scale score is the sum of responses.

  7. Dutch Heart Failure Knowledge Scale

    Time frame: 90 days

    15-item questionnaire assesses heart failure knowledge in general, knowledge on heart failure treatment (including diet and fluid restriction) and heart failure symptoms and symptom recognition. Each correct answer gets one point and total score ranges from 0 to 15.

  8. Minnesota Living with Heart Failure Questionnaire

    Time frame: 90 days

    21-item questionnaire assesses HF specific quality of life, using a 6-point Likert scale with item scores ranging from 0 to 5, scale score is the sum of responses.

  9. The Medical Outcome Study 36-Item Short Form

    Time frame: 90 days

    36-item quality of life instrument used to evaluate perception of general health status, functional ability, and well-being.

  10. Usability survey

    Time frame: 90 days

    31-item scale developed for this study to assess the participants' satisfaction with 7 aspects of the intervention using a 7-point Likert scale with item scores ranging from 1 to 7 (7 being best), and total score is the mean of responses. Patients were also asked open-ended questions in order to obtain an in-depth understanding of individual experiences, perceptions, concerns and feedback.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • James and Esther King Biomedical Research Program

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 17, 2016
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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